SPL v1
SPL
SPL Set ID 613e3f65-0461-42a2-ad6b-e1e83c142d23
Route
TOPICAL
Published
Effective Date 2020-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (72 mL)
Inactive Ingredients
Water Carbomer Homopolymer, Unspecified Type Aloe Green Tea Leaf Hyaluronate Sodium Aminomethylpropanol Glycerin Orange Oil Polysorbate 20 Potassium Hydroxide .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01

Description

Ethyl alcohol 72% v/v

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

Ethyl alcohol 72% v/v

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

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Do not use

• in children less than 2 months of age

• on open skin wounds

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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Active Ingredient

Ethyl alcohol 72% v/v

Other Information

• Store between 15-30℃ (59-86℉)

• Avoid freezing and excessive heat above 40℃ (104℉)

Inactive Ingredients

Water, carbomer, aloe extract, green tea extract, sodium hyaluronate, aminomethyl propanol, glycerin, orange oil, polysorbate 20, potassium hydroxide, tocopheryl acetate

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label: Tns Mediplus Hand Sanitizer 100ml

Package Label: Tns Mediplus Hand Sanitizer 500ml

Package Label: Tns Mediplus Hand Sanitizer 1000ml


Structured Label Content

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

For external use only. Flammable. Keep away from heat or flame

--------------------------------------------------------------------------------------------------------

Do not use

• in children less than 2 months of age

• on open skin wounds

--------------------------------------------------------------------------------------------------------

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Active Ingredient (ACTIVE INGREDIENT)

Ethyl alcohol 72% v/v

Other Information

• Store between 15-30℃ (59-86℉)

• Avoid freezing and excessive heat above 40℃ (104℉)

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, carbomer, aloe extract, green tea extract, sodium hyaluronate, aminomethyl propanol, glycerin, orange oil, polysorbate 20, potassium hydroxide, tocopheryl acetate

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label: Tns Mediplus Hand Sanitizer 100ml (Package Label: TNS MEDIPLUS HAND SANITIZER 100mL)

Package Label: Tns Mediplus Hand Sanitizer 500ml (Package Label: TNS MEDIPLUS HAND SANITIZER 500mL)

Package Label: Tns Mediplus Hand Sanitizer 1000ml (Package Label: TNS MEDIPLUS HAND SANITIZER 1000mL)


Advanced Ingredient Data


Raw Label Data

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